A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
Recruiting
Phase 2Interventional Study
Biliary Tract Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
151 (estimated)
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
Who this trial is looking for
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This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18-75 years old (including both ends), male or female;
2. ECOG-PS score: 0 or 1;
3. Expected survival ≥ 12 weeks;
4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
5. CLDN18.2 positive expression;
6. Subjects who failed or int…
Inclusion Criteria:
1. Age 18-75 years old (including both ends), male or female;
2. ECOG-PS score: 0 or 1;
3. Expected survival ≥ 12 weeks;
4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
5. CLDN18.2 positive expression;
6. Subjects who failed or intolerance after systemic chemotherapies;
7. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
8. The main organ function is normal, in line with the program requirements;
9. Consent to contraception.
Exclusion Criteria:
1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
2. Other active malignancies within 5 years or at the same time;
3. Subjects with a history or evidence of brain metastasis or meningeal metastasis;
4. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
5. Severe trauma or major surgery was performed within 4 weeks before the first administration;
6. To study the severe heart disease within 6 months before the first administration;
7. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
8. Severe infection symptoms occurred within 2 weeks before the first administration;
9. Known hereditary or acquired bleeding and thrombotic tendency;
10. Congenital or acquired immune defects;
11. The subjects had severe and uncontrollable concomitant diseases;
12. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.
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